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Study of Ripretinib vs Sunitinib for Patients with Advanced Gastrointestinal Stromal Tumor with Specific KIT Exon Mutations Previously Treated with Imatinib

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as Advanced Gastrointestinal Stromal Tumor (GIST). This is a rare cancer that occurs in the digestive tract, most commonly in the stomach or small intestine. The study is comparing two treatments: Ripretinib and Sunitinib. Ripretinib, also known by its code name DCC-2618, is a medication that targets specific proteins involved in cancer growth. Sunitinib is another medication used to treat certain types of cancer by blocking the action of proteins that promote tumor growth.

The purpose of the study is to compare the effectiveness of Ripretinib and Sunitinib in patients with advanced GIST who have specific genetic changes called KIT Exon 11 and Co-occurring KIT Exons 17 and/or 18 Mutations. These mutations are changes in the DNA that can affect how cancer grows and responds to treatment. Patients in this study have previously been treated with another medication called Imatinib but need further treatment due to the progression of their disease.

Participants in the study will be randomly assigned to receive either Ripretinib or Sunitinib. The study will last for a period of up to 24 months, during which time the patients will take the medication orally in the form of tablets or capsules. The progress of the disease will be monitored through regular medical assessments to determine how well the treatment is working. The study aims to provide valuable information on which treatment may be more effective for patients with this specific type of GIST.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be randomly assigned to receive either ripretinib or sunitinib. This means you will not choose which medication you receive, but it will be decided by chance.

  2. Step 2

    Medication administration

    If you are assigned to ripretinib, you will take a 50 mg tablet orally once a day. If you are assigned to sunitinib, you will take a 12.5 mg hard capsule orally once a day.

    The duration of taking the medication will be determined by the study's progress and your response to the treatment.

  3. Step 3

    Regular health assessments

    Throughout the study, you will undergo regular health assessments. These assessments will include physical exams, blood tests, and imaging tests to monitor the progression of your condition and your response to the medication.

  4. Step 4

    Progress evaluation

    Your progress will be evaluated based on how long you live without your disease getting worse, known as progression-free survival. This will be assessed by independent radiologic review, which means experts will review your test results to determine the status of your condition.

  5. Step 5

    Completion of the study

    The study is expected to continue until April 16, 2027. Your participation may end earlier if your condition changes or if you decide to withdraw from the study.

Who can join the trial?

5 criteria

  • Must be a male or female who is 18 years of age or older.
  • Must have a confirmed diagnosis of Gastrointestinal Stromal Tumor (GIST) with specific genetic changes called KIT exons 11+17/18 mutations. This will be confirmed by a blood test analyzed by a central laboratory.
  • Must have advanced GIST and show signs of the disease getting worse after treatment with a drug called imatinib. Treatment with imatinib must have been stopped at least 10 days before starting the study medication.
  • Must have an ECOG Performance Status of 0, 1, or 2 at screening. This is a scale used to assess how the disease affects daily living abilities, where 0 means fully active and 2 means capable of all self-care but unable to carry out any work activities.
  • Female participants who can have children must have a negative pregnancy test at the start of the study and before the first dose of the study medication.

Who cannot join the trial?

4 criteria

  • Patients with any other type of cancer that is not an Advanced Gastrointestinal Stromal Tumor.
  • Patients who have not been diagnosed with KIT exon 11+17/18 mutations. This refers to specific genetic changes in the tumor.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Ripretinib

    is a medication used in this clinical trial to treat patients with a type of cancer called gastrointestinal stromal tumor (GIST). It works by blocking certain proteins that help cancer cells grow. By doing this, ripretinib can help slow down or stop the growth of the tumor. This medication is being tested to see how well it works compared to another treatment option for patients who have specific genetic mutations in their cancer.

  • Sunitinib

    is another medication being tested in this trial for treating advanced gastrointestinal stromal tumors (GIST). It is designed to target and block proteins that are involved in the growth and spread of cancer cells. Sunitinib is already used in treating certain types of cancer, and in this study, it is being compared to ripretinib to see which one is more effective for patients with specific genetic mutations in their tumors.

What is already known about the treatment

  • Ripretinib

    Ripretinib is administered orally in the form of tablets and is currently being studied in clinical trials for its effectiveness in treating advanced gastrointestinal stromal tumors (GIST) with specific genetic mutations. It is designed to help patients who have already been treated with another medication called Imatinib. Ripretinib works by blocking certain proteins that promote tumor growth, specifically targeting mutations in the KIT gene. It is classified as a tyrosine kinase inhibitor, which is a type of drug that interferes with the signals that cause cancer cells to grow.

  • Sunitinib

    Sunitinib is also taken orally as a capsule and is being compared to Ripretinib in clinical trials for treating advanced gastrointestinal stromal tumors (GIST) with specific genetic mutations. It is used for patients who have previously been treated with Imatinib. Sunitinib works by inhibiting multiple proteins that are involved in the growth and spread of cancer cells, including those in the KIT gene. It belongs to the pharmacological class of tyrosine kinase inhibitors, which help to slow down or stop the growth of cancer cells.

Investigated diseases

Advanced Gastrointestinal Stromal Tumor – This is a type of cancer that occurs in the digestive tract, most commonly in the stomach or small intestine. It originates from special cells in the gastrointestinal tract wall known as interstitial cells of Cajal. The disease progresses as the tumor grows and may spread to other parts of the body. Symptoms can include abdominal pain, a feeling of fullness, and gastrointestinal bleeding. As the tumor advances, it can lead to complications such as obstruction of the digestive tract. The progression of the disease is often monitored through imaging studies to assess changes in tumor size and spread.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-503058-37-00Protocol codeDCC-2618-03-003Estimated enrolment56 patientsSponsorDeciphera Pharmaceuticals Inc.

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